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PURPOSE: The purpose of this review and meta-analysis is to determine the clinical outcome differences between patients with chronic limb-threatening ischemia who underwent direct versus indirect angiosome revascularization using either the surgical or endovascular approach. MATERIALS AND METHODS: The data sources used for article selection included PubMed, Embase/Medline, Cochrane reviews, and Web of Science (All studies were in English and included up to September 2023). All articles included were comparative in design, including retrospective, prospective, and randomized controlled trials that compared the clinical outcomes between direct and indirect angiosome-guided revascularization in chronic limb-threatening ischemia. A random-effects model was used to determine the measure of association between direct revascularization and amputation-free survival, wound healing, and overall survival. Publication bias was assessed with both Begg's and Egger's test, and heterogeneity was calculated using an I2. RESULTS: Data from 9 articles were analyzed and reported in this review. Direct revascularization was associated with improved amputation-free survival (odds ratio [OR]=2.632, confidence interval [CI]: 1.625, 4.265), binary wound healing (OR=2.262, CI: 1.518, 3.372), and overall survival (OR=1.757, CI: 1.176, 2.625). Time until wound healed was not associated with either direct or indirect revascularization (Standard Mean Difference [SMD]=-2.15, p=0.11). There was a low risk of bias across all studies according to the RoB 2.0 tool. CONCLUSION: Direct revascularization is associated with improved amputation-free survival, overall survival, and wound healing in chronic limb-threatening ischemic patients compared to the indirect approach. CLINICAL IMPACT: Preservation of the lower extremity is critical for preventing mortality and maintaining independence. The benefit of angiosome-guided revascularization for chronic limb-threatening ischemia remains controversial. The authors of this article aim to review the current literature and compare direct and indirect angiosome-guided intervention for preserving the lower extremity. Current findings suggest direct angiosome-guided intervention reduces amputation rates and improves survival; however, many trials neglect to address the multifactorial approach needed in wound care management.
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The aim of this study was to compare outcomes of moderate and severe foot infections in people with and without diabetes mellitus (DM). We retrospectively evaluated 382 patients (77% with DM and 23% non-DM). We collected demographic data, co-morbidities and one-year outcomes including healing, surgical interventions, number of surgeries, length of stay, re-infection and re-hospitalisation. DM patients required more surgeries (2.3 ± 2.2 vs. 1.7 ± 1.3, p = 0.01), but did not have a longer hospital length of stay during the index hospitalisation (DM 10.9 days ±9.2 vs. non-DM = 8.8 days ±5.8, p = 0.43). After the index hospitalisation, DM patients had increased rates of re-hospitalisation for any reason (63.3% vs. 35.2%, CI 1.9-5.2, OR 3.2, p < 0.01), re-infection at the index wound infection site (48% vs. 30.7%, CI 1.3-3.5, OR 2.1, p < 0.01), re-hospitalisation for a foot pathology (47.3% vs. 29.5%, CI 1.3-3.6, OR 2.1, p < 0.01), and longer times to ulcer healing (151.8 days ±108.8 vs. 108.8 ± 90.6 days, p = 0.04). Patients with DM admitted to hospital with foot infections have worse clinical outcomes during the index hospitalisation and are more likely to have re-infection and re-admission to hospital in the next year.
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Pie Diabético , Tiempo de Internación , Cicatrización de Heridas , Humanos , Pie Diabético/microbiología , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Tiempo de Internación/estadística & datos numéricos , Infección de Heridas/epidemiología , Infección de Heridas/microbiología , Readmisión del Paciente/estadística & datos numéricos , Amputación Quirúrgica/estadística & datos numéricosRESUMEN
The aim of this study was to evaluate the diagnostic characteristics of biomarker for diabetic foot osteomyelitis (DFO). We searched PubMed, Scopus, Embase and Medline for studies who report serological markers and DFO before December 2022. Studies must include at least one of the following diagnostic parameters for biomarkers: area under the curve, sensitivities, specificities, positive predictive value, negative predictive value. Two authors evaluated quality using the Quality Assessment of Diagnostic Accuracy Studies tool. We included 19 papers. In this systematic review, there were 2854 subjects with 2134 (74.8%) of those patients being included in the meta-analysis. The most common biomarkers were erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and procalcitonin (PCT). A meta-analysis was then performed where data were evaluated with Forrest plots and receiver operating characteristic curves. The pooled sensitivity and specificity were 0.72 and 0.75 for PCT, 0.72 and 0.76 for CRP and 0.70 and 0.77 for ESR. Pooled area under the curves for ESR, CRP and PCT were 0.83, 0.77 and 0.71, respectfully. Average diagnostic odds ratios were 16.1 (range 3.6-55.4), 14.3 (range 2.7-48.7) and 6.7 (range 3.6-10.4) for ESR, CRP and PCT, respectfully. None of the biomarkers we evaluated could be rated as 'outstanding' to diagnose osteomyelitis. Based on the areas under the curve, ESR is an 'excellent' biomarker to detect osteomyelitis, and CRP and PCT are 'acceptable' biomarkers to diagnose osteomyelitis. Diagnostic odds ratios indicate that ESR, CRP and PCT are 'good' or 'very good' tools to identify osteomyelitis.
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Biomarcadores , Pie Diabético , Osteomielitis , Humanos , Pie Diabético/diagnóstico , Pie Diabético/sangre , Osteomielitis/diagnóstico , Osteomielitis/sangre , Biomarcadores/sangre , Proteína C-Reactiva/análisis , Proteína C-Reactiva/metabolismo , Polipéptido alfa Relacionado con Calcitonina/sangre , Sedimentación Sanguínea , Sensibilidad y Especificidad , Curva ROCRESUMEN
Our objective was to evaluate normative data for near-infrared spectroscopy (NIRS) in 110 healthy volunteers by Fitzpatrick skin type (FST) and region of the foot. We obtained measurements of the dorsum and plantar foot using a commercially available device (SnapshotNIR, Kent Imaging, Calgary Canada). On the dorsum of the foot, people with FST6 had significantly lower oxygen saturation compared to FST1-5 (p < 0.001), lower oxyhaemoglobin compared to FST2-5 (p = 0.001), but there was no difference in deoxyhaemoglobin. No differences were found on the plantar foot. When comparing dorsal and plantar foot, there was higher oxyhaemoglobin (0.40 ± 0.09 vs. 0.51 ± 0.12, p < 0.001) and deoxyhaemoglobin (0.16 ± 0.05 vs. 0.21 ± 0.05, p < 0.001) on the plantar foot, but no differences in oxygen saturation (dorsal 70.7 ± 10.8, plantar 70.0 ± 9.5, p = 0.414). In 6.4% of feet, there were black areas, for which no NIRS measurements could be generated. All areas with no data were on the dorsal foot and only found in FST 5-6. People with FST6 had significantly larger areas with no data compared to FST 5 (22.2 cm2 ± 20.4 vs. 1.9 cm2 ± 0.90, p = 0.007). These findings should be considered when using NIRS technology. Skin pigmentation should be evaluated in future NIRS studies.
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Saturación de Oxígeno , Espectroscopía Infrarroja Corta , Humanos , Voluntarios Sanos , Oxihemoglobinas , PieRESUMEN
BACKGROUND: Nitinol interwoven bare metal stents represent an advancement in stent technology; however, nominal deployment remains an area of focus. Intravascular ultrasound (IVUS) has been shown to improve outcomes in both the coronary and peripheral vasculature by providing the operator with greater vessel detail; however, the use of adjunctive IVUS with nitinol bare metal stents has not been widely studied. This studies aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions. DESIGN: Retrospective study. METHODS: This study included a cohort of 200 consecutive patients with peripheral artery disease. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event. RESULTS: The patients who received IVUS had a significantly greater number of nominally deployed stents (p<0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p=0.047). CONCLUSION: The IVUS and angiography decreases clinically-driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents. CLINICAL IMPACT: Endovascular surgones may conisder the adjuctive use of IVUS when using the Supera stent for the treatment of infra inguinal superficial femoral artery lesions. The adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultiamtely reduction in CD-TLR.
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BACKGROUND: Chronic diseases and their associated health outcomes have been known to disproportionately affect people of low socioeconomic status (SES) around the world. The authors aim to examine the association between SES and nontraumatic lower extremity amputation. METHODS: A search of current literature was performed in March 2022 across PubMed, Scopus, Embase, and Medline for relevant literature. Keywords included "socioeconomics", "income", "amputation", and "lower extremities". RESULTS: A total of 1,164,630 patients across 5 studies were incorporated into the meta-analysis of nontraumatic lower extremity amputation and SES. An additional 3 citations were used in the secondary analyses between gender and ethnicity and their relationship with amputation. An association was observed between low SES and nontraumatic lower extremity amputations, odds ratio (OR) = 1.168, (confidence interval [CI]: 1.153, 1.183) P ≤ 0.05. Gender and race subanalyses were also conducted, with associations found with men and non-Caucasians with amputation: OR = 1.044; [CI: 1.036, 1.053] P ≤ 0.05; race OR = 2.893; [CI: 2.866, 2.920] P ≤ 0.05. CONCLUSIONS: SES along with gender and race are associated with nontraumatic lower extremity amputation. These findings add additional perspectives for which populations are disproportionately affected by disease and subsequent health outcomes. The authors anticipate the results presented may further assist in future public health screening methods and interventions. LEVEL OF CLINICAL EVIDENCE: 2.
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Amputación Quirúrgica , Extremidad Inferior , Masculino , Humanos , Factores de Riesgo , Resultado del Tratamiento , Extremidad Inferior/cirugía , Oportunidad RelativaRESUMEN
This review and meta-analysis aims to assess the prognostic value of the Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) score for detecting necrotizing fasciitis in the extremities. The LRINEC score has been validated in multiple studies as a clinical tool for differentiating necrotizing fasciitis from non-necrotizing infections however many studies do not specify the location of infection. As the prevalence of diabetes and diabetic foot infections continues to rise, the utility of LRINEC scores in these populations becomes of increased importance. Four databases were reviewed for citations between January 2010 and December 2020. English, full text articles reporting the diagnostic effects of LRINEC were utilized in the systematic review portion of this paper. Further inclusion of 2 × 2 tables and discussion specific to the extremities were applied for citations implemented in the meta-analysis. Of the 111 results, 12 citations (n = 932) were included in this review. The diagnostic sensitivity of the LRINEC score ranged from 36% to 77% while specificity ranged from 72% to 93%. Cumulative odds ratio for LRINEC ≥6 among the 4 studies assessing extremity necrotizing fasciitis was 4.3 with p value of <.05. Sensitivity, specificity, positive predictive value, and negative predictive value was 49.39%, 83.17%, 34.91%, and 89.99%, respectively. Accuracy, the classification by whether a patient was correctly classified, was 77.95%. LRINEC score is effective at distinguishing necrotizing fasciitis from other soft tissue infections however the LRINEC's score greatest clinical application may be its ability to rule out necrotizing fasciitis while its ability to accurately identify the presence of infection remains suboptimal.
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Fascitis Necrotizante , Infecciones de los Tejidos Blandos , Fascitis Necrotizante/diagnóstico , Humanos , Extremidad Inferior , Estudios Retrospectivos , Factores de Riesgo , Infecciones de los Tejidos Blandos/diagnósticoRESUMEN
OBJECTIVE: To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. MATERIALS AND METHODS: Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. RESULTS: The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008). CONCLUSIONS: There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.
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Aterectomía , Dispositivos de Protección Embólica , Embolia , Arteria Femoral , Extremidad Inferior , Enfermedad Arterial Periférica/cirugía , Complicaciones Posoperatorias , Aterectomía/efectos adversos , Aterectomía/métodos , Dispositivos de Protección Embólica/efectos adversos , Dispositivos de Protección Embólica/clasificación , Dispositivos de Protección Embólica/estadística & datos numéricos , Embolia/etiología , Embolia/prevención & control , Femenino , Arteria Femoral/patología , Arteria Femoral/cirugía , Humanos , Extremidad Inferior/irrigación sanguínea , Extremidad Inferior/cirugía , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Resultado del TratamientoRESUMEN
Venous stasis ulcers represent the majority of lower-extremity ulcers and place a considerable financial burden on the American health care system. Current standard of care therapies remain sub-optimal with 50% of venous stasis ulcers remaining unhealed after 4 months. Sixteen consecutive wounds were enrolled across 8 participants at a single center and underwent pH-driven therapy in addition to standard care as dictated by physicians. Following wound debridement, the pH of the wound bed was measured using pH strips. If acidic, normal saline was used to rinse the wound at every dressing change. If alkaline, nonsterile gauze was soaked in 0.25% acetic acid and applied to the wound for a minimum of 30 seconds. Participants were followed for 4 weeks with research staff observing compliance throughout. All 16 wounds had an alkaline pH at baseline, with an average pH of 8.25 ± 0.55 (range 7.5 to 9). Average area of the wound at the time of enrollment was (mean ± standard deviation) 285.48 ± 43.68 mm2, and average age of the wound was 37.5 ± 20.3 months (range 3 to 72). A simple linear regression model found a moderate relationship between pH and the rate of healing of chronic nonhealing venous stasis lower-extremity wounds (correlation coefficient⯠=â¯0.61). For every 1-unit change in pH, we can expect to see a change in wound size of 116.05 mm2. This is the first US-based, open-label, prospective study that examined the effect of pH on the rate of healing in chronic nonhealing venous stasis ulcer lowerextremity wounds.
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Úlcera Varicosa , Niño , Preescolar , Enfermedad Crónica , Humanos , Concentración de Iones de Hidrógeno , Lactante , Extremidad Inferior , Estudios Prospectivos , Úlcera Varicosa/terapia , Cicatrización de HeridasRESUMEN
Diabetes mellitus (DM) and chronic kidney disease (CKD) separately are known to facilitate the progression of medial arterial calcification (MAC) in patients with symptomatic peripheral artery disease (PAD), but their combined effect on MAC and associated mediators of calcification is not well studied. The association of MAC and calcification inducer bone morphogenetic protein (BMP-2) and inhibitor fetuin-A, with PAD, is well known. Our aim was to investigate the association of MAC with alterations in BMP-2 and fetuin-A protein expression in patients with PAD with DM and/or CKD. Peripheral artery plaques (50) collected during directional atherectomy from symptomatic patients with PAD were evaluated, grouped into no-DM/no-CKD (n = 14), DM alone (n = 10), CKD alone (n = 12), and DM+CKD (n = 14). MAC density was evaluated using hematoxylin and eosin, and alizarin red stain. Analysis of inflammation, neovascularization, BMP-2 and fetuin-A protein density was performed by immunohistochemistry. MAC density, inflammation grade and neovessel content were significantly higher in DM+CKD versus no-DM/no-CKD and CKD (p < 0.01). BMP-2 protein density was significantly higher in DM+CKD versus all other groups (p < 0.01), whereas fetuin-A protein density was significantly lower in DM+CKD versus all other groups (p < 0.001). The combined presence of DM+CKD may be associated with MAC severity in PAD plaques more so than DM or CKD alone, as illustrated in this study, where levels of calcification mediators BMP-2 and fetuin-A protein were related most robustly to DM+CKD. Further understanding of mechanisms involved in mediating calcification and their association with DM and CKD may be useful in improving management and developing therapeutic interventions.
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Proteína Morfogenética Ósea 2/análisis , Complicaciones de la Diabetes/etiología , Arteria Femoral/química , Enfermedad Arterial Periférica/etiología , Insuficiencia Renal Crónica/complicaciones , Calcificación Vascular/etiología , alfa-2-Glicoproteína-HS/análisis , Anciano , Anciano de 80 o más Años , Biomarcadores/análisis , Estudios Transversales , Complicaciones de la Diabetes/diagnóstico , Complicaciones de la Diabetes/metabolismo , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/metabolismo , Pronóstico , Insuficiencia Renal Crónica/diagnóstico , Medición de Riesgo , Factores de Riesgo , Calcificación Vascular/diagnóstico , Calcificación Vascular/metabolismoRESUMEN
PURPOSE: To investigate the impact on restenosis rates of deep injury to the adventitial layer during directional atherectomy. METHODS: Between 2007 and 2010, 116 consecutive patients (mean age 69.6 years; 56 men) with symptomatic femoropopliteal stenoses were treated with directional atherectomy at a single center. All patients had claudication and TASC A/B lesions in the superficial femoral or popliteal arteries. Histopathology analysis of atherectomy specimens was performed to identify adventitial injury. Clinical follow-up included physical examination and duplex ultrasound scans at 3, 6, and 12 months in all patients. The primary endpoint was the duplex-documented 1-year rate of restenosis, which was determined by a peak systolic velocity ratio <2.4. Patients were dichotomized by the presence or absence of adventitial or medial cuts as evaluated by histopathology. RESULTS: Adventitial injury were identified in 62 (53%) of patients. There were no differences in baseline demographic and clinical features (p>0.05), lesion length (58.7±12.8 vs 56.2±13.6 mm, p=0.40), or vessel runoff (1.9±0.6 vs 2.0±0.6, p=0.37) between patients with and without adventitial injury, respectively. The overall 1-year incidence of restenosis was 57%, but the rate was significantly higher (p<0.0001) in patients with adventitial or medial injury (97%, 60/62) as compared with those without (11%, 6/54). CONCLUSION: Lack of adventitial injury after atherectomy for femoropopliteal stenosis is strongly related to patency at 1 year.
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Adventicia/lesiones , Aterectomía/efectos adversos , Arteria Femoral/lesiones , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/lesiones , Túnica Media/lesiones , Lesiones del Sistema Vascular/etiología , Adventicia/patología , Anciano , Anciano de 80 o más Años , Constricción Patológica , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/patología , Arteria Femoral/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/patología , Arteria Poplítea/fisiopatología , Recurrencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Túnica Media/patología , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular , Lesiones del Sistema Vascular/diagnóstico , Lesiones del Sistema Vascular/fisiopatologíaRESUMEN
This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease. Clinicaltrials.gov Registration:NCT01858428.
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OBJECTIVE: Haptoglobin (Hp) protein is responsible for hemoglobin clearance after intra-plaque hemorrhage. Hp gene exists as Hp-1 and Hp-2 alleles and the phenotypes show important molecular heterogeneity. We tested the hypothesis that hemoglobin clearance may be deficient in diabetic atheroma from patients with Hp2-2, triggering increased oxidative, inflammatory, and angiogenic patterns compared with controls. METHODS AND RESULTS: Forty patients with diabetes mellitus were genotyped and their peripheral plaques compared after atherectomy. Plaque hemorrhage, iron content, hemoglobin-binding protein CD163, and heme-oxygenase-1 were quantified. Oxidative, inflammatory, and angiogenic patterns were evaluated by measuring myeloperoxidase, interleukin-10, macrophages, vascular cell adhesion molecule-1, smooth muscle actin, and plaque neovascularization (CD34/CD31). Plaques with Hp2-2 (n=7) had increased hemorrhage (P<0.005), iron content (P<0.001), and reduced CD163 expression (P<0.002) compared with controls (n=14). Hp2-2 plaques had increased heme-oxygenase-1 protein (P<0.02), myeloperoxidase gene (P<0.05), and protein (P<0.0001). Anti-inflammatory interleukin-10 gene (P<0.04), and protein expressions (P<0.0001) were decreased in Hp2-2. Finally, macrophage (P<0.0001), vascular cell adhesion molecule-1 (P=0.001), smooth muscle actin (P=0.002) scores, and neovessels density (P<0.0001) were increased in Hp2-2. CONCLUSIONS: Genotype-dependent impairment of hemoglobin clearance after intra-plaque hemorrhage is associated with increased oxidative, inflammatory, and angiogenic response in human diabetic atherosclerosis.
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Aterosclerosis/genética , Diabetes Mellitus/genética , Angiopatías Diabéticas/genética , Haptoglobinas/genética , Hemoglobinas/metabolismo , Inflamación/genética , Estrés Oxidativo/genética , Actinas/metabolismo , Anciano , Antígenos CD/metabolismo , Antígenos de Diferenciación Mielomonocítica/metabolismo , Aterosclerosis/sangre , Aterosclerosis/inmunología , Aterosclerosis/patología , Aterosclerosis/cirugía , Biomarcadores/metabolismo , Estudios de Casos y Controles , Diabetes Mellitus/sangre , Diabetes Mellitus/inmunología , Angiopatías Diabéticas/sangre , Angiopatías Diabéticas/inmunología , Angiopatías Diabéticas/patología , Angiopatías Diabéticas/cirugía , Femenino , Genotipo , Haptoglobinas/metabolismo , Hemo-Oxigenasa 1/metabolismo , Humanos , Inflamación/sangre , Inflamación/inmunología , Interleucina-10/metabolismo , Hierro/metabolismo , Masculino , Persona de Mediana Edad , Neovascularización Patológica , Peroxidasa/metabolismo , Fenotipo , Estudios Prospectivos , Receptores de Superficie Celular/metabolismo , Molécula 1 de Adhesión Celular Vascular/metabolismoRESUMEN
INTRODUCTION: The benefits of NPWT-T for the diabetic foot have been established. The addition of regular periodic irrigation with broad-spectrum antiseptic solution has been shown to reduce bioburden and total bacterial colonies; however, debate remains as to the clinical effect on diabetic foot outcomes. OBJECTIVE: This study investigated the differences between NPWT-T and NPWT-I for treatment of the diabetic foot and the associated clinical outcomes. METHODS: PubMed, Medline/Embase, the Cochrane Library, and Web of Science were searched for relevant literature published between January 1, 2002, and March 1, 2022. Keywords included "Negative Pressure Wound Therapy" AND "Instillation" OR "Irrigation." Three studies with a total of 421 patients (NPWT-T [n = 223], NPWT-I [n = 198]) were included in the meta-analysis. RESULTS: No significant differences were observed between NPWT-T and NPWT-I for BWC (OR, 1.049; 95% CI, 0.709-1.552; P =.810), time to wound closure (SMD, -0.039; 95% CI, -0.233-0.154; P =.691), LOS (SMD, 0.065; 95% CI, -0.128-0.259; P =.508), or AEs (OR, 1.092; 95% CI, 0.714-1.670; P =.69). CONCLUSION: Results of this systematic review and meta-analysis indicate that further RCTs are required to assess the role of NPWT-I in the management of DFU and DFI.
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Diabetes Mellitus , Pie Diabético , Terapia de Presión Negativa para Heridas , Humanos , Pie Diabético/terapia , Cicatrización de Heridas , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia de Presión Negativa para Heridas/métodosRESUMEN
BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.
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Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Resultado del Tratamiento , Factores de Riesgo , Procedimientos Quirúrgicos Vasculares/efectos adversos , Arteria Femoral/cirugía , Procedimientos Endovasculares/efectos adversos , Estudios Retrospectivos , Recuperación del Miembro , Grado de Desobstrucción Vascular , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
Aterectomía/efectos adversos , Arteria Femoral/lesiones , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/lesiones , Túnica Media/lesiones , Lesiones del Sistema Vascular/etiología , Aterectomía/métodos , Arteria Femoral/diagnóstico por imagen , Humanos , Arteria Poplítea/diagnóstico por imagen , Túnica Media/diagnóstico por imagen , Ultrasonografía Intervencional , Lesiones del Sistema Vascular/diagnóstico por imagenRESUMEN
Sub-Optimal deployment of Self expanding interwoven stents (Supera) has been shown to increase the rate of Clinically Driven Target Lesion Revascularization (CD-TLR). Meanwhile, drug coated balloons (DCB) have been shown to reduce CD-TLR in the femoral-popliteal segment in de- novo and restenotic lesions. However, the clinical effects of vessel preparation with DCB in nominal, compressed, and elongated Supera has not been widely studied. The purpose of this study is to assess the outcomes of clinically driven re-intervention, major amputations, and mortality in relation to the use of DCB as vessel preparation in different deployment conditions (nominal, compressed, elongated) of the Supera stent. Patient chart data was collected at a single center hospital between March 2015 and May 2020. All patients were adults (≥ 18 years old) and were treated with at least one (≥ 1) Supera stent. Deployment status was extrapolated from anonymized angiograms. The primary endpoint of this study was CD-TLR. Secondary endpoints included amputation and mortality rates associated with each deployment condition. A total of 670 limbs were treated and patients were followed for 36 months. Nominal stent deployment was observed in 337 limbs, followed by elongated condition (n = 176), then by compressed conditions (n = 159). CD-TLR was observed most frequently with elongated deployment. Drug coated balloons were used as vessel prep prior to stenting and showed a protective effect regardless of deployment status; O.R = 0.44 (CI 0.30-0.66, p < .05).
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Enfermedad Arterial Periférica , Arteria Poplítea , Adulto , Humanos , Adolescente , Arteria Femoral/cirugía , Enfermedad Arterial Periférica/terapia , Grado de Desobstrucción Vascular , Resultado del Tratamiento , Materiales Biocompatibles RevestidosRESUMEN
Background: End-stage ankle osteoarthritis often requires one of 2 major surgical procedures: total ankle arthroplasty or ankle arthrodesis. Although the gold standard has been arthrodesis, patients with diabetes represent a unique cohort that requires additional considerations because of their decreased mobility and risk factors for cardiovascular complications. The purpose of this study is to review odds of major and minor adverse events for patients with diabetes and patients without diabetes in both total ankle arthroplasty and ankle arthrodesis. Methods: A total of 14 articles published between 2010 and 2020 were included in this review. Databases included PubMed, Scopus, MEDLINE/Embase, and Cochrane Library. Key words included ankle arthroplasty, total ankle arthroplasty, ankle arthrodesis, and diabetes. Results: The total number of procedures was 26 287, comprising 13 830 arthroplasty and 12 457 arthrodesis procedures. There was a significant association between patients with diabetes treated with arthrodesis and major adverse events (odds ratio [OR] 1.880, 95% CI 1.279, 2.762), whereas no significant association was observed between patients with diabetes treated with arthroplasty and major adverse events (OR 1.106, 95% CI 0.871, 1.404). Conclusion: This meta-analysis suggests patients with diabetes to be at significantly higher risk for major and minor adverse events after undergoing ankle arthrodesis. However, it suggests no significant differences in major adverse events between patients with diabetes and patients without diabetes having undergone total ankle arthroplasty. Level of Evidence: Level III, systematic review and meta-analysis.
RESUMEN
We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.
Asunto(s)
Isquemia Crónica que Amenaza las Extremidades , Enfermedad Arterial Periférica , Aleaciones , Amputación Quirúrgica , Estudios de Seguimiento , Humanos , Isquemia , Recuperación del Miembro , Arteria Poplítea , Diseño de Prótesis , Estudios Retrospectivos , Stents , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Drug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor understanding of the underlying mechanisms. OBJECTIVES: The authors sought to investigate the determinants of DCB failure in femoropopliteal disease. METHODS: Data from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure. RESULTS: Included were 557 participants with single lesions and 12-month core laboratory-adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk. CONCLUSIONS: Patency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA]; NCT01947478; IN.PACT Global Clinical Study; NCT01609296).